Phase 0 Trial of Gallium-68 tris-hydroxypyridinone prostate specific membrane antigen (Ga-68 THP-PSMA) positron emission tomography (PET) scanning for prostate cancer

In patients with prostate cancer, what is the uptake in tumours and normal tissue on positron emission tomography (PET) following administration of Ga-68 THP-PSMA?

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001324505

Enrollment

Registered

2015-12-03

Start date

2015-12-04

Completion date

2017-02-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of this study is to test the safety as well as define the normal and abnormal scan appearances following injection of a radioactive substance called Gallium-68 tris-hydroxypyridinone – prostate specific membrane antigen (Ga-68 THP-PSMA) and imaging with positron emission tomography (PET). Who is it for? You may be eligible to join this study if you have prostate adenocarcinoma and are scheduled to undergo a prostatectomy. Study details: In this study, we will use a radioactive molecule (called Gallium-68) that, after injection into a vein, specifically attaches to prostate cancer cells by binding to a receptor called PSMA. You will need to visit the hospital for an additional occasion for approximately 4 hours. An intravenous line will be inserted into a vein in each arm, one to give the investigational product, and another for sampling your blood during the scan. Ga-68 THP-PSMA will be injected and several scans performed over a 3 hour period. You will be closely observed throughout this period with regular recording of your vital signs. The radioactive molecule used in this study is not approved by the Therapeutic Goods Administration (TGA). This study will help inform the utility of this agent for imaging prostate cancer, and design of future larger studies assessing accuracy.

Interventions

Positron emission tomography / computed tomography (PET/CT) scan following intravenous administration of Gallium-68 THP-PSMA - administered activity of 250 MBq as a single bolus administration - scanning commencing following injection encompassing field-of-view from vertex to upper thighs immediately - total duration of imaging 3 hours

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Age 18 – 80 years 2. Proven adenocarcinoma of the prostate gland. 3. All patients have to be suitable for surgical treatment as part of their normal management 4. Able to comply with treatment plans, scheduled visits, all study PET imaging and follow-up

Exclusion criteria

1. Any prior treatment for the prostate gland tumours

Outcome results